Improving Affordability in Cancer Care Through Economic Screening and Support (I-ACCESS) (I-ACCESS)
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
In Aim 1, we will interview up to 30 clinical leaders and front-line staff across the two healthcare systems and community-based practices to understand workflows and opportunities for I-ACCESS integration. Assessment constructs will focus on understanding structural characteristics (including information technology infrastructure), available resources, culture, compatibility, relational connections, communications, and access to knowledge. These data will inform the creation of tailored process maps to outline processes and procedures to prepare each site for I-ACCESS implementation and elucidate when, how, and by whom I-ACCESS screening should be done.
In Aim 2, we will implement I-ACCESS as part of routine clinical practice for eight months at each site. Using a pre-/post-approach, we will examine whether I-ACCESS screening increases the number of financial counseling and oncology social work referrals (primary outcome). We will also examine counseling dispositions, receipt of services among those referred to financial support, and the predictive accuracy of the screening tool (secondary outcomes).
In Aim 3, we will analyze approximately 225 patient and 25 clinician surveys, informed by the Practical, Robust, Implementation and Sustainability Model, to gather feedback on I-ACCESS delivery, procedures, and barriers/facilitators to implementation. Based upon survey findings, we will then focus on key implementation determinants and outcomes through in-depth, semi-structured interviews with up to 40 stakeholders. Stakeholders will include patients, caregivers, healthcare providers, financial counselors, clinical support staff, and hospital administration at participating clinical sites.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Brianna Connelly
- Número de teléfono: 919-964-2343
- Correo electrónico: brianna_connelly@med.unc.edu
Ubicaciones de estudio
-
-
New York
-
New York, New York, Estados Unidos, 10016
- Perlmutter Cancer Center
-
Contacto:
- Brianna Connelly
- Número de teléfono: 919-964-2343
- Correo electrónico: brianna_connelly@med.unc.edu
-
Contacto:
- Bridgette
- Número de teléfono: 646-221-6953
- Correo electrónico: Bridgette.Thom@unc.edu
-
-
North Carolina
-
Burlington, North Carolina, Estados Unidos, 27215
- Cone Health Alamance Regional
-
Contacto:
- Brianna Connelly
- Número de teléfono: 919-964-2343
- Correo electrónico: brianna_connelly@med.unc.edu
-
Contacto:
- Bridgette Thom
- Número de teléfono: 646-221-6953
- Correo electrónico: Bridgette.Thom@unc.edu
-
Chapel Hill, North Carolina, Estados Unidos, 27599
- University of North Carolina at Chapel Hill
-
Hendersonville, North Carolina, Estados Unidos, 28791
- UNC Health Pardee
-
Contacto:
- Brianna Connelly
- Número de teléfono: 919-964-2343
- Correo electrónico: brianna_connelly@med.unc.edu
-
Contacto:
- Bridgette Thom
- Número de teléfono: 646-221-6953
- Correo electrónico: Bridgette.Thom@unc.edu
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Patients: Treatment for cancer at study site, over age 18 years, speak/read English or Spanish; Caregivers: Identified caregiver of a patient with cancer offered financial hardship screening, over age 18 years, speak/read English or Spanish; Staff/Clinicians: Involvement with I-ACCESS pilot implementation; over age 18 years, speak/read English or Spanish
Exclusion Criteria:
- Unable to read of speak English or Spanish
- Under the age of 18 years old
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: Financial Screener
Determine the effectiveness of the I-ACCESS screening tool in facilitating patient referrals for financial hardship counseling across diverse clinical practice settings.
Patients who meet inclusion criteria will be screened for financial toxicity for financial toxicity using a 2-question screener tool developed from the COST ( a financial toxicity screening measure).
Patients who screen positive for financial toxicity will be appropriately referred to available counseling resources.
|
Patients who screen positive for financial toxicity on the 2-question screener tool, will be referred to available counseling or navigation resources available at each site.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Screening completion
Periodo de tiempo: From enrollment to the end of the intervention at 8 months.
|
Ratio of the number of completed screens to the number of eligible patients
|
From enrollment to the end of the intervention at 8 months.
|
|
Rate of referral assistance
Periodo de tiempo: From enrollment to the end of the intervention at 8 months.
|
Ratio of the number of patients referred to counseling to the number of patients screened positive for financial distress
|
From enrollment to the end of the intervention at 8 months.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Type of referral
Periodo de tiempo: From enrollment to the end of the intervention at 8 months.
|
Count/percent of reason for referral (out-of-pocket costs, non-medical expense, benefit counseling, medication cost, other)
|
From enrollment to the end of the intervention at 8 months.
|
|
Counseling content
Periodo de tiempo: From enrollment to the end of the intervention at 8 months.
|
Count/percent of counseling disposition (general, insurance, external referral, other)
|
From enrollment to the end of the intervention at 8 months.
|
|
Applications for assistance
Periodo de tiempo: From enrollment to the end of the intervention at 8 months.
|
Count/percent of external referrals (including, but not limited to, foundation/charity support, local non-medical expense resources)
|
From enrollment to the end of the intervention at 8 months.
|
|
Referrals to external resources
Periodo de tiempo: From enrollment to the end of the intervention at 8 months.
|
Count/percent of external referrals (including, but not limited to, foundation/charity support, local non-medical expense resources)
|
From enrollment to the end of the intervention at 8 months.
|
|
Predictive accuracy of tool
Periodo de tiempo: From enrollment through the end of data analysis at 12 months
|
Sensitivity, specificity, positive predictive value, and negative predictive value of tool vs. documented bill-paying challenges
|
From enrollment through the end of data analysis at 12 months
|
|
Acceptability of Intervention Measure
Periodo de tiempo: 4-6 months after implementation of I-ACCESS
|
Patient and clinician perception of intervention acceptability
|
4-6 months after implementation of I-ACCESS
|
|
Intervention Appropriateness Measure
Periodo de tiempo: 4-6 months after implementation of I-ACCESS
|
Patient and clinician perception of intervention appropriateness
|
4-6 months after implementation of I-ACCESS
|
|
Feasibility of Intervention Measure
Periodo de tiempo: 4-6 months after intervention completion
|
Patient and clinician perception of intervention feasibility
|
4-6 months after intervention completion
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 25-1413
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .